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Triple Drug Therapy for Advanced Melanoma
Study Summary
This trial is testing a combination of three drugs to treat melanoma that has spread and has a certain type of abnormal gene. One of the drugs is given as an IV infusion, and the other two are taken orally at home every day. The team will monitor how each participant is doing with the treatment during regular visits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- You have at least one detectable abnormality that can be seen on a scan or in a photo according to certain guidelines.You have signs of hepatitis B or C virus infection.I haven't had any cancer except for certain skin, prostate, or cervical pre-cancers in the last 2 years.My melanoma has a BRAF V600 mutation confirmed by a certified test.I have tested positive for HIV/AIDS.I stopped taking encorafenib, binimetinib, or anti-PD-1/-L1 due to severe side effects.You have severe allergies to multiple medications, cannot tolerate topical corticosteroids, or have severe reactions after treatment.I am using or might need drugs that strongly affect how my body processes some medications.I have or had lung inflammation not caused by infection, treated with steroids.I have or had brain metastases or cancer spread to the lining of the brain.I have recovered from major side effects of my previous cancer treatments.I haven't had systemic therapy for advanced melanoma.I cannot swallow or absorb pills.I have not had a stroke or blood clot in the last 3 months.I have not been treated for an infection with medication in the last 2 weeks.You have a medical or mental condition, or recent thoughts of harming yourself, that could make it risky for you to be in the study.My melanoma is located in the mucosal or ocular area.I am not allergic to encorafenib, binimetinib, pembrolizumab, or their ingredients.I can provide a sample of my tumor for testing.My bone marrow, liver, and kidneys are functioning well.I am 18 years old or older.My skin cancer is at an advanced stage and cannot be surgically removed.I am willing and able to follow all study requirements.I have a muscle disorder that could increase my CK levels.I have a serious heart condition.I am fully active or can carry out light work.I have an immune system disorder that needed treatment in the last 2 years.I am able to understand and sign the consent form.I have a digestive issue that affects how my body absorbs medication.I have or am at risk for retinal vein occlusion.
- Group 1: Control Arm
- Group 2: Triplet Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What previous research exists on Pembrolizumab's effectiveness?
"Pembrolizumab is being studied in 1055 active clinical trials, with 125 of those research programs in Phase 3. Although a significant portion of the Pembrolizumab studies are based in Sacramento, California, there are over 39 thousand locations worldwide where Pembrolizumab trials are taking place."
Where are patients able to participate in this trial?
"This clinical trial has numerous locations, with the three primary ones being Utah Cancer Specialists in Provo, Utah; Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug) in Los Angeles, California; and McGill University Health Centre - Glen Site in Montreal, Quebec."
How many people are currently enrolled in this clinical trial?
"Yes, an online search of clinicaltrials.gov supports that this study is looking for participants. This particular trial was first posted on 1/15/2021 and was last updated on 11/2/2022. They are recruiting 624 total patients from 56 different sites."
What are some of the key benefits that Pembrolizumab has been shown to provide patients?
"Pembrolizumab is the standard of care for malignant neoplasms. This immunotherapy can also improve patient outcomes for those with microsatellite instability high, unresectable melanoma, and disease progression after chemotherapy."
Is it still possible for people to join this research project?
"This study, as advertised on clinicaltrials.gov, is seeking participants. The listing was first posted on 1/15/2021 and last updated on 11/2/2022."
What is the Pembrolizumab FDA approval process?
"There is some efficacy data and multiple rounds of safety data, so Pembrolizumab scored a 3 in terms of safety."
What is the purpose of this medical study?
"The primary goal of this study is to assess the progression-free survival (PFS) of patients over the course of two treatment cycles (21 days each). This will be evaluated by blinded independent central review. Secondary outcomes include changes in quality of life, as measured by the Functional Assessment of Cancer Therapy-Melanoma subscale score, and the incidence and severity of adverse events."
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